Devices › System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Device brand name · Vascular stent graft
Fluency Plus Vascular Stent Graft: medical device reports filed with FDA
736 reports name it, 2017–2026. Manufacturer given most often on reports: Angiomed & Medizintechnik Kg. Product code PFV.
- 736
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 64
- reports, 12 months to August 2026
- 43 in the 12 months before
- 92%
- classified as malfunction
- 68.3% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
736 medical device reports received by FDA name the brand "Fluency Plus Vascular Stent Graft" (vascular stent graft); the manufacturer given most often on reports is Angiomed & Medizintechnik Kg; received from June 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
64 reports arrived in the 12 months to August 2026, up 49% from 43 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (92%), injury (7.6%) and death (0.4%); across all system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment reports (product code PFV) death is recorded in 1.1% and malfunction in 68.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are misfire (62.5%), positioning failure (49.5%) and fracture (45%). The patient problems coded most often are hemorrhage/blood loss/bleeding, appropriate clinical signs, symptoms and conditions term/code not available and no patient involvement. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,762 reports carrying product code PFV. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Misfire | 460 | 62.5% | 30.3% |
| Positioning failure | 364 | 49.5% | 31.4% |
| Fracturea broken bone | 331 | 45% | 20.8% |
| Breakthe device broke | 111 | 15.1% | 13.5% |
| Detachment of device or device componentpart of the device came off | 50 | 6.8% | 6.8% |
| Difficult to removethe device was hard to remove | 44 | 6% | 3.1% |
| Material deformation | 41 | 5.6% | 6.4% |
| Retraction problem | 35 | 4.8% | 2.1% |
| Difficult or delayed positioning | 24 | 3.3% | 2.8% |
| Activation failure | 22 | 3% | 6.1% |
| Material perforation | 22 | 3% | 5.6% |
| Malposition of device | 18 | 2.4% | 3.2% |
| Positioning problem | 18 | 2.4% | 1.6% |
| Difficult to advance | 13 | 1.8% | 1.6% |
| Obstruction of flow | 12 | 1.6% | 4.8% |
| Device-device incompatibility | 10 | 1.4% | 0.8% |
| Failure to advance | 9 | 1.2% | 1.3% |
| Entrapment of device | 6 | 0.8% | 1.1% |
| Material invagination | 5 | 0.7% | 0.8% |
| Activation, positioning or separation problem | 4 | 0.5% | 1.4% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 10 | 1.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 9 | 1.2% |
| No patient involvement | 8 | 1.1% |
| Injurya physical injury | 7 | 1% |
| Thrombosis | 5 | 0.7% |
| Encephalopathy | 4 | 0.5% |
| Stenosis | 4 | 0.5% |
| Thrombosis/thrombus | 4 | 0.5% |
| Aneurysm | 3 | 0.4% |
| Occlusion | 3 | 0.4% |
| Perforation of vessels | 3 | 0.4% |
| Restenosis | 3 | 0.4% |
| Abscessa collection of pus | 2 | 0.3% |
| Deaththe patient died; cause not stated by this term | 2 | 0.3% |
| Device embedded in tissue or plaque | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fluency Plus Vascular Stent Graft | Product code PFV | All MAUDE reports |
|---|---|---|---|
| Reports | 736 | 2,762 | 26,136,888 |
| Share of that pool | — | 26.6% | 0% |
| Classified as death, per 1,000 reports | 4 | 11 | 9 |
| Classified as injury | 7.6% | 30.6% | 36.2% |
| Classified as malfunction | 92% | 68.3% | 62.3% |
| Filed by the manufacturer | 100% | 99.4% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code PFV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fluency Plus Endovascular Stent Graft | 635 | 35 | 0.6% |
| Gore Viabahn Endoprosthesis - 3 | 354 | 0 | 3.1% |
| Covera Vascular Covered Stent | 338 | 42 | 0.3% |
| GORE VIABAHN Endoprosthesis | 985 | 18 | 5.8% |
| GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface | 906 | 174 | 2.1% |
| Flair Endovascular Stent Graft | 375 | 0 | 0.3% |
| GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface | 341 | 91 | 0.6% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Fluency Plus Vascular Stent Graft reports
How many FDA reports name Fluency Plus Vascular Stent Graft?
736 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 64 in the latest 12 months.
What kinds of events are reported?
malfunction (92%), injury (7.6%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
misfire (62.5%), positioning failure (49.5%), fracture (45%), break (15.1%) and detachment of device or device component (6.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Fluency Plus Vascular Stent Graft was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.